American Regent recalls 25 mg/10 mL niCARdipine Hydrochloride Injection vials with potential sterility risks. Leaking vial necks could cause contamination. Affected lots expire through June 2026.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
American Regent is recalling niCARdipine Hydrochloride Injection vials that may leak around the neck, risking contamination. This could lead to infections if the medication is used without proper sterility.
Leakage around the vial neck during storage or handling could allow contaminants to enter the medication. This might compromise sterility, increasing infection risk during injection.
Healthcare professionals using this prescription medication for blood pressure. Patients receiving the injection under medical supervision are at low risk if the vial is used correctly.
Check for vials labeled 'niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only'. Look for specific lots: 24086N0C0 (expiring 7/31/2025), 24076N0C0, 24090N0C0 (expiring 8/31/2025), or 25011N0C0 (expiring 6/30/2026).
Identify the lot number on the vial label to determine if it's affected (24086N0C0, 24076N0C0, 24090N0C0, or 25011N0C0).
The product may have leakage risks that could compromise sterility. If you have the affected lot numbers, contact American Regent for guidance.
Check for vials labeled 'niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only' with specific lot numbers: 24086N0C0 (expiring 7/31/2025), 24076N0C0, 24090N0C0 (expiring 8/31/2025), or 25011N0C0 (expiring 6/30/2026).
Contact American Regent directly to confirm if your vial is affected and get instructions for safe handling or disposal.
We’ve drafted a message you can send American Regent to request your refund or repair — edit it as you like.
Subject: Recall D-0399-2025 — American Regent American Regent Hello, I own a American Regent that is covered by recall D-0399-2025 from American Regent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
